Back to top

Analyst Blog

Gilead Sciences, Inc. (GILD - Analyst Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently rendered a positive opinion on its HIV combination pill, Stribild (formerly known as Quad). Stribild is a combination of elvitegravir, cobicistat and Truvada. We note that Truvada itself is a combination of Viread and Emtriva.

The CHMP recommended the approval of Stribild for treating HIV infected adults who are either antiretroviral-naïve or are HIV infected without known mutations associated with resistance to any of the components of Stribild.

Management at Gilead stated that it expects a final decision on its Marketing Authorisation Application (MAA) for Stribild in the coming months. Gilead filed the MAA last year on the basis of encouraging data from two phase III studies -- 102, which compared Stribild to Atripla and 103, which compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. While Norvir is marketed by AbbVie Inc. (ABBV - Analyst Report), Reyataz is marketed by Bristol-Myers Squibb (BMY - Analyst Report).

We note that Stribild was approved in the US in Aug 2012 for treating HIV infected treatment-naïve adults. The drug is also approved in Canada, South Korea and Australia. European approval will further boost the sales potential of the drug.

We note that elvitegravir and cobicistat (2 of the components of Stribild) are under review in the US. A final decision from the US Food and Drug Administration (FDA) on elvitegravir is expected by Apr 27, 2013. The FDA is expected to decide on cobicistat, as a standalone agent, by Apr 28, 2013.

Gilead carries a Zacks Rank #3 (Hold). Osiris Therapeutics, Inc. (OSIR - Analyst Report) looks more attractive in the pharma space. The stock carries a Zacks Rank #1 (Strong Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
CENTURY ALU… CENX 22.53 +4.50%
ERBA DIAGNO… ERB 2.91 +4.30%
PLANAR SYST… PLNR 4.31 +3.86%
MALLINCKROD… MNK 72.17 +3.83%
GTT COMMUNI… GTT 12.06 +3.52%